Evaluation of SWT Efficiency in Alleviation of Chronic Prostate Inflammation

Michael Abdijev, MD

Source: Clinical Study Report, May 2014

Bulgaria

76% improvement of quality of life

The BTL-6000 SWT subjects have met the primary efficacy outcome measure by achieving a minimum of 50% of symptom alleviation in 50% of subjects after the last treatment with results lasting at the same level or being deteriorated by ≤10% at 90-day follow up.

Abstract

Purpose & Primary Objective:

This study was designed to investigate the effectiveness of extracorporeal shock wave therapy (ESWT) for symptoms alleviation in patients with chronic pelvic pain syndrome (CPPS).

The primary efficacy outcome is set to be a minimum of 50% of symptom alleviation in 50% of subjects after the last treatment with results lasting at the same level or being deteriorated by ≤10% at 90-day follow up.

Methods:

Twenty nine male subjects of 27-70 years of age suffering from chronic pelvic pain for more than 3 months and having no addiction to drugs or narcotics were observed. All subjects received 4 treatments over 4-week period, with BTL-6000 SWT unit.

Results:

All subjects completed the treatment and 30-day follow-up. All but two subjects completed 90-day follow-up. After the last treatment, twenty four subjects (82,76%) showed ≥50% alleviation of the pelvic pain and urinary symptoms. Mean symptom alleviation through all 29 patients was 68%. Mean symptom alleviation after 30-day follow-up showed result of 73%. After 90-day follow up was mean symptom alleviation was back at 68%.

According to the response to the treatment, patients could be divided into two groups. In one group pre- and post-treatment evaluations showed significant reduction of symptoms (≥50%), from moderate to mild on Symptom Scale Score (SSS), with difference 5-15 points of the SSS.

In the second group, three subjects had relief from severe to moderate symptoms (even though two subjects did not comply the symptom alleviation ≥50%).Yet even another three subjects had highly significant relief from severe to mild symptoms on SSS, with difference of 11-16 points of the SSS.

The BTL-6000 SWT subjects have met the primary efficacy outcome measure by achieving a minimum of 50% of symptom alleviation in 50% of subjects after the last treatment with results lasting at the same level or being deteriorated by ≤10% at 90-day follow-up.